New trial will test keratin and its effects on nerve regeneration

Researchers at the Wake Forest University Baptist Medical Center have been given a grant which will allow them to carry out a study into keratin gel and its effectiveness in regenerating nerves in the arms, hands and feet.

The grant was awarded to the university from the U.S Department of Defense(DOD) and totals $2.4 m. The keratin gel,which is derived from hair, was invented by the Institute for Regenerative Medicine at the university. The gel has already undergone pre-clinical testing and was found to be effective in promoting the growth of severed nerves. The keratin gel is said to aid the growth of peripheral nerves by increasing axons, a structure in the nervous system that enables signals to be carried to and from the spinal cord. According to the press release nearly 3% of patients who receive medical care at a Level 1 trauma centre in the US have some form of nerve injury. The DOD say that the most common injury to soldiers in Afghanistan and Iraq are blast and shrapnel injuries which as well as causing damage to the skin and bones can cause nerve damage. In a press release Doctor Zhongyu Li explained the standard way that patients with severed nerves are treated: “Right now the standard treatment for severed nerves is to use a graft of the patient’s own nerve to repair the damaged one." “In essence, you have to sacrifice a good nerve to fix the one that has been injured. When you do that, the patient loses some sensation in the nerve used for the graft, and the damaged nerve still may fail to repair itself and regain function.” I asked Doctor Zhongyu Li about the part that keratin gel plays in nerve regeneration. He explained: "It works as a 3D nerve growth guide by providing an extracellular matrix mimic, the natural condition which supports Schwann cell (the supporting cells for the nerve) migration, proliferation and maturation, and provides a growth cue for the growing nerve." Taking part in the trial will be patients that have suffered a traumatic injury of the nerves in their fingers or forearm, Dr Li said. Once approved by the U.S. Food and Drug Administration 10 people will take part in phase 0 of the trial to check the safety of the gel. Dr. Li says that the next phase of the trial will involve "a randomized trail comparing 2 treatment methods for nerve repair: 1) repair of an injured nerve with a FDA approved nerve conduit, 2) repair of an injured nerve with a FDA approved nerve conduit filled with keratin gel." The gel also has the potential to be beneficial to nerve injuries in other areas of the human body says Dr. Li. Talking about the aims of the trial, Dr.Li said “Our goal is to encourage better regeneration of the nerves through the use of this gel, and hopefully improve results for both small and large nerve gaps in traumatic nerve injuries." Each of the groups involved in the trial will be assessed in two years time to see how well the nerve injury has healed. In 2008 scientists from the Wake Forest University School of Medicine tested keratin on animals and found that the protein was able to speed up the regeneration and improve the function of nerves.